Posted by Michael Wonder on 01 Dec 2023
FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukaemia and small lymphocytic lymphoma
1 December 2023 - Today, the FDA granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly) for adults with chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
Efficacy was evaluated in BRUIN, an open-label, international, single-arm, multi-cohort trial that included 108 patients with CLL or SLL previously treated with at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
